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Comparative Study of Tranexamic Acid, Estrogen for Treatment AUB in DMPA Users

Primary Purpose

Abnormal Uterine Bleeding, Tranexamic Acid, Estrogen

Status
Not yet recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Tranexamic acid 250 mg oral tablet
Progynova 1 mg oral tablet
Sponsored by
Rajavithi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abnormal Uterine Bleeding focused on measuring AUB, DMPA, Tranexamic acid, Estrogen

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Abnormal uterine bleeding more than 7 days after first DMPA injection Provide inform consent with patient Can understand thai language Exclusion Criteria: Have contraindication to use Tranexamic acid and estrogen such as hypertension, Stroke, MI, DM, Renal disease, Liver disease, CA breast etc. Have pathology in uterus from pelvic examination, pap smear and ultrasound Current pelvic infection Postpartum less than 6 months History deep vein thrombosis Breastfeeding

Sites / Locations

  • Krittiporn Mahachiraphat
  • Krittiporn Mahachiraphat, M.D.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tranexamic acid

Progynova

Arm Description

Tranexamic acid 250 mg oral three times/day

Progynova 1 mg oral three times/day

Outcomes

Primary Outcome Measures

Day to stop abnormal uterine bleeding between groups after receiving Tranexamic acid and estrogen
To Compare day to stop abnormal uterine bleeding between groups after receiving Tranexamic acid and estrogen

Secondary Outcome Measures

Side effect after receiving Tranexamic acid
To study side effect after receiving Tranexamic acid
Side effect after receiving estrogen
To study side effect after receiving estrogen
Frequency of bleeding after DMPA injection
To study frequency of bleeding after DMPA injection

Full Information

First Posted
September 13, 2023
Last Updated
September 27, 2023
Sponsor
Rajavithi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06067217
Brief Title
Comparative Study of Tranexamic Acid, Estrogen for Treatment AUB in DMPA Users
Official Title
Comparative Study of Tranexamic Acid, Estrogen for Treatment Abnormal Uterine Bleeding in Depot-medroxyprogesterone Acetate Users. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Abnormal uterine bleeding is the most common problems to discontinue Depo-medroxyprogesterone acetate (DMPA) in Thailand. This clinical trial use to provide drug to stop abnormal uterine bleeding from DMPA
Detailed Description
Abnormal uterine bleeding is the most common problems to discontinue Depo-medroxyprogesterone acetate (DMPA) in Thailand. After discontinue DMPA, patients have not used any method. Unwanted pregnancy are rising. The reason of abnormal uterine bleeding from DMPA aren't clearly understand. In present, no standard treatment to treat abnormal utrerine bleeding in DMPA users.This clinical trial use to provide drug to stop abnormal uterine bleeding from DMPA with minimal dose and minimal side effect

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abnormal Uterine Bleeding, Tranexamic Acid, Estrogen, Depot Medroxyprogesterone Acetate
Keywords
AUB, DMPA, Tranexamic acid, Estrogen

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Drug in concealed envelop which participant and care provider aren't see
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid
Arm Type
Experimental
Arm Description
Tranexamic acid 250 mg oral three times/day
Arm Title
Progynova
Arm Type
Experimental
Arm Description
Progynova 1 mg oral three times/day
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid 250 mg oral tablet
Intervention Description
Compare between tranexamic acid and progynova to stop abnormal uterine bleeding in DMPA users
Intervention Type
Drug
Intervention Name(s)
Progynova 1 mg oral tablet
Intervention Description
Compare between tranexamic acid and progynova to stop abnormal uterine bleeding in DMPA users
Primary Outcome Measure Information:
Title
Day to stop abnormal uterine bleeding between groups after receiving Tranexamic acid and estrogen
Description
To Compare day to stop abnormal uterine bleeding between groups after receiving Tranexamic acid and estrogen
Time Frame
1 week after intervention
Secondary Outcome Measure Information:
Title
Side effect after receiving Tranexamic acid
Description
To study side effect after receiving Tranexamic acid
Time Frame
1 week after intervention
Title
Side effect after receiving estrogen
Description
To study side effect after receiving estrogen
Time Frame
1 week after intervention
Title
Frequency of bleeding after DMPA injection
Description
To study frequency of bleeding after DMPA injection
Time Frame
after DMPA injection

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Abnormal uterine bleeding more than 7 days after first DMPA injection Provide inform consent with patient Can understand thai language Exclusion Criteria: Have contraindication to use Tranexamic acid and estrogen such as hypertension, Stroke, MI, DM, Renal disease, Liver disease, CA breast etc. Have pathology in uterus from pelvic examination, pap smear and ultrasound Current pelvic infection Postpartum less than 6 months History deep vein thrombosis Breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Krittiporn Mahachiraphat, M.D.
Phone
0877996647
Email
qqq_ruttew@live.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sitanan Lertsiripanich, M.D.
Phone
0829727222
Email
sitanan.lert@gmail.com
Facility Information:
Facility Name
Krittiporn Mahachiraphat
City
Bangkok
State/Province
Ratchathewi
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Krittiporn Mahachiraphat, M.D.
City
Phaya Thai
State/Province
Ratchathewi
ZIP/Postal Code
10400
Country
Thailand
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krittiporn Mahachiraphat, M.D.
Phone
0877996647
Email
qqq_ruttew@live.com
First Name & Middle Initial & Last Name & Degree
Sitanan Lertsiripanich, M.D.
Phone
0829727222
Email
sitanan.lert@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparative Study of Tranexamic Acid, Estrogen for Treatment AUB in DMPA Users

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